The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to ...

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good ...

Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA" training has been added to ResearchAndMarkets.com's offering. cGMP or current good ...

Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its self-developed, GMP-grade high-purity vaccine adjuvant AB-801 has received an ...

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public ...

The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency. The ...

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.

Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "Good Manufacturing Practices (GMP) 101" training has been added to ResearchAndMarkets.com's offering. This GMP Compliance training course is designed to ...

The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Nov 13, 2025)" training has been added to ResearchAndMarkets.com's offering. cGMP or current good manufacturing practices are ...

Protracted correspondence between drugmakers and the FDA in sorting out the fixes to GMP violations is likely becoming a high-risk undertaking. The FDA has indicated that from here on in, it will have ...